Sr QA Manager, CLS

<h2>Job Overview:</h2><p style="margin: 0in 0in 0pt 17.85pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">The Senior QA Manager will assure all systems, processes, and their outcomes comply with standards that meet applicable international and national regulations, guidelines and fulfill client and Covance requirements.</span></p><p style="margin: 0in 0in 0pt 17.85pt;"> </p><p style="margin: 0in 0in 0pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Essential job duties listed below (* indicates potential direct client interaction)</span></p><ul><li style="color: #000000;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Provides leadership for a QA team by ensuring individuals have the appropriate education, training and experience to fulfill their role.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Designs and delivers appropriate training material and trains and mentors team as required.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Ensures resources are available to appropriately execute QA processes, mitigate compliance risks and provide quality oversight of the sites operations.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Performs/supports internal/vendor audits.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Hosts client and regulatory inspections.*</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Acts as QA Management representative during strategic client interactions.*</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Accountable for budgetary planning and cost control for their assigned areas of responsibility.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Identifies and leads departmental and/or company projects/initiatives. Leads process improvement and harmonization efforts that promote best practices.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Provides management support and guidance during issue management resolution .*</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Provides regulatory/industry/company consultation and guidance as needed.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Develops/revises SOPs/other controlled documents.</span></li></ul><p style="margin: 0in 0in 0pt 17.85pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Other essential job duties as assigned by management.</span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;"> </p><h2 style="margin: 0in 0in 0pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Minimum Required:</span></h2><ul><li style="color: #000000;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Bachelor’s Degree or equivalent experience – Science related field preferred.</span></li></ul><h2>Experience:</h2><h2 style="margin: 0in 0in 0pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Minimum Required:</span></h2><ul><li style="color: #000000;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Minimum of 8 Years of experience in the job discipline or other related roles. Prefer working experience in CAP, ISO 15189 and undertand GCP and clinical trial</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">Demonstrated understanding of Quality Assurance in a regulated laboratory environment</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: arial,helvetica,sans-serif; font-size: 8pt;">People management experience</span></li></ul>